Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01113918
First received: April 28, 2010
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are potentially dangerous in women health. Early diagnosis and prevention is very important to the PCOS patients.

Obesity is the most potential risk of threat to health of populations. There is a major impact of obesity on the PCOS related disorders. Insulin resistance and distribution of adipose tissue were thought to be the important risk factors of cardiovascular and metabolic syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team. We recently published in "Fertility and Sterility" about the clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is important to know that some clinical presentation of PCOS might have ethic variance. Insulin resistance was reported as another candidate that might have ethic variance.We had reported about 40% women in PCOS women were obese, it is similar with previous literature reported. Obesity is a major factor that could be controlled during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS women would be facing the risks of diabetes and metabolic syndrome.We thought like to evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.

Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research which including gynecological endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This team had been working well for more that 4 years.

We hope we can make a contribution to the study and treatment of PCOS in Taiwan.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Study of Clinical Presentation and Cardiovascular Disease of Hyperandrogenism and Polycystic Ovary Syndrome in Obese and Non-obese Taiwanese Women

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Obese [ Time Frame: Who had visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center during April 2004 - March 2007. ] [ Designated as safety issue: No ]

Enrollment: 627
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obsity PCOS Women

Polycystic ovary syndrome (PCOS) was diagnosed according to the European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM) case definition which requires presentation of signs and/or symptoms of a minimum of 2 of the following 3 criteria: polycystic ovary morphology (PCOM), oligomenorrhea or amenorrhea (Oligo-An), androgen excess (HA).

Body mass index (BMI) was defined as body weight in kilograms divided by body height in meters squared (kg/m2). Obesity was defined as BMI≥25 kg/m2, according to the Asia-Pacific definition.

Non-obesity PCOS Women
The subjects BMI were less than ≥25 kg/m2 and out of criteria of PCOS by European Society for Human Reproduction (ESHRE)/American Society of Reproductive Medicine (ASRM).

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Polycystic Ovarian Syndrome(PCOS) women in wanfang hospital.

Criteria

Inclusion Criteria:

  • women who had visited the Reproductive Endocrinology Clinic at Taipei Medical University - Wan Fang Medical Center during April 2004 - March 2007 with the chief complaints of menstrual irregularities, infertility, acne/or hirsutism.

Exclusion Criteria:

  • women who had been diagnosed with androgen-secreting tumors.
  • girls who had their menarche less than 3 years prior to the study, or who older than 40.
  • women with inadequate clinical/biochemical records.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113918

Locations
Taiwan
Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01113918     History of Changes
Other Study ID Numbers: WFH-PCOS-97070
Study First Received: April 28, 2010
Last Updated: September 29, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Obesity,
PCOS,
HA,
CVD

Additional relevant MeSH terms:
Cardiovascular Diseases
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014